Surgical Curette, Various
FDA 510(k) K841004 · Premier Dental Products Co.
510(k) numberK841004
Submission
- Device name
- Surgical Curette, Various
- Applicant
- Premier Dental Products Co.
Mchenry, IL, US - Received
- March 9, 1984
- Decision date
- May 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HCY – Curette, Uterine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980096 | Oac (Optical Aspirating Curette)HCY · Traditional | Imagyn Medical Technologies, Inc. | 05/01/1998SE |
| K944238 | Endocyte TMHCY · Traditional | D.L. Nelson and Assoc., Inc. | 09/15/1995SE |
| K935822 | Phase I CuretteHCY · Traditional | Phase I Corp. | 04/28/1994SE |
| K901442 | Baxter D & C TrayHCY · Traditional | Baxter Healthcare Corp | 07/26/1990SE |
| K890384 | Uterine CuretteHCY · Traditional | Kinetic Medical Products | 02/13/1989SE |
| K881794 | Ivory Finder SetHCY · Traditional | Ivory Instruments Co. | 07/08/1988SE |
| K862297 | The D & C Pad-SacHCY · Traditional | Nu-Gyn-Tek, Inc. | 07/07/1986SE |
| K850068 | Lune Au CurettesHCY · Traditional | Luneau Laboratories | 04/08/1985SE |
| K802313 | Uterine CuretteHCY · Traditional | Gynemetrics, Inc. | 01/12/1981SE |
| K790032 | Disposable Vacuum CuretteHCY · Traditional | British Marketing Ent., Ltd. | 02/01/1979SE |
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Questions and answers
When was Surgical Curette, Various cleared by the FDA?
Surgical Curette, Various (K841004) received a 510(k) decision of Substantially Equivalent on May 11, 1984, 63 days after the submission was received.
What is the product code of K841004?
The FDA product code is HCY – Curette, Uterine, a Class I (low risk) device regulated under 21 CFR 884.4530.